Filamentous tissue implant

ABSTRACT

A tissue fixation system including a delivery tube and an elongated fastener with a loop at a proximal end and a distal end. A proximal end of an elongated curved needle is attached to the delivery tube. A distal end of the needle is configured to penetrate tissue. The needle includes an open channel sized to receive the elongated fastener with the loop located near the proximal end of the elongated curved needle and the distal end of the elongated fastener located near the distal end of the elongated curved needle. A capture needle is slidably positioned in the delivery tube to slide through the loop in the proximal end of the elongated fastener. The capture needle is configured to grasp the distal end of the elongated fastener and pull the distal end of the elongated fastener through the loop to cinch the elongated fastener.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/591,147, filed on Jan. 7, 2015, which is a continuation of U.S.patent application Ser. No. 13/383,956, filed on May 3, 2012, which is aU.S. National Application under 35 U.S.C § 371 of International PatentApplication Number PCT/US2010/036190, filed on May 26, 2010, whichclaims priority to U.S. Provisional Application No. 61/180,935, filedMay 26, 2009, the contents of which are incorporated herein by referencein their entirety.

FIELD OF THE INVENTION

The present disclosure relates generally to tissue fixation devices,systems and methods. In particular, the present disclosure provides atissue fastening device which provides simplified fixation of tissue tostructures such as implantable mesh and other tissue.

BACKGROUND OF THE INVENTION

Numerous devices have been used to fasten tissue to another structure,including other tissue. Filament is provided in various types, used incombination with a needle to sew tissue. Mechanical clips are used tomechanically fixate tissue, similar to stapling. Many tissue fixationdevices and methods are dependent on technique and can result inadequate attachment or undesirable long term effects such as scarring.There is therefore a need for improved tissue fixation devices, systemsand methods.

BRIEF SUMMARY OF THE INVENTION

The present disclosure is directed to several unique tissue fasteners,tissue fixation systems and tissue fixation methods that providesimplified, repeatable and reliable fixation of tissue to one or morestructures and/or to other tissue.

One embodiment of the tissue fixation system includes a delivery tubeand an elongated fastener with a loop at a proximal end and a distalend. A proximal end of an elongated curved needle is attached to thedelivery tube. A distal end of the needle is configured to penetrate orencircle tissue. The needle includes an open channel sized to receivethe elongated fastener with the loop located near the proximal end ofthe elongated curved needle and the distal end of the elongated fastenerlocated near the distal end of the elongated curved needle. A captureneedle is slidably positioned in the delivery tube to slide through theloop in the proximal end of the elongated fastener. The capture needleis configured to grasp the distal end of the elongated fastener and pullthe distal end of the elongated fastener through the loop to cinch theelongated fastener.

The capture needle preferably mechanically engages with the distal endof the elongated fastener. The distal end of the elongated fasteneroptionally includes a loop.

The proximal end of the elongated fastener can be multi-filamentstructure and the distal portion of the elongated fastener includes oneor more interlock structures configured to self-lock with the proximalend.

In another embodiment, the proximal end is a hollow multi-filamentsleeve sized to receive, and self-lock with interlock structures formedat the distal end of the fastener. The interlock structures areconfigured to penetrate the proximal end. Alternatively, the interlockstructures can be located along an interior surface of the sleeveportion. In one embodiment, the distal portion of the elongated fasteneris a monofilament and the multi-filament sleeve extends along a portionof the mono filament.

Interlock structure can be prongs, barbs, protrusions, hooks,extensions, teeth, textured surfaces, and the like. The interlockstructures can be discrete features added to the self-locking fastener;molded or extruded as part of the self-locking fastener; formed bypost-processing the self-locking fastener; and/or a variety of otherapproaches. In one embodiment, the first portion of the fastener is aloop structure and the second portion is a hook structure, such as in ahook-and-loop fastener.

The elongated fastener optionally includes rigid portions. The distalend of the elongated fastener optionally deforms either plastically orelastically. The elongated fastener is optionally bioabsorbablematerial. The elongated fastener can be constructed of a materialselected from the group consisting of: polylactide, poylglycolide,polysaccharides, proteins, polyesters, polyhydroxyal kanoates,polyalkelene esters, polyamides, polycaprolactone, polyvinyl esters,polyamide esters, polyvinyl alcohols, polyanhydrides polyolefins, PEEK,PTFE, and their copolymers, modified derivatives of caprolactonepolymers, polytrimethylene carbonate, polyacrylates, polyethyleneglycol, hydrogels, photo-curable hydrogels, terminal diols, andcombinations thereof. The elongated fastener optionally includes metalfilaments, such as for example Nitinol, configured to provide aresilient bias, either along, or in combination with polymericfilaments.

In one embodiment, the curved needle includes a rolled sheet. The openchannel is created by unrolling the penetrating portion. In anotherembodiment, the capture needle includes jaws configured to transitionfrom an open to a closed position. An energy source is optionallyprovided to bond distal end of the elongated fastener to the loop. Theenergy can be one or more of heat and/or ultrasonic energy.

The present disclosure is also directed to a method of engaging thetissue fixation system with two or more layers of material. Theelongated fastener is loaded in the open channel of the elongated curvedneedle with the loop located near the proximal end of the elongatedcurved needle and the distal end of the elongated fastener located nearthe distal end of the elongated curved needle. The distal end of thecurved needled is inserted though two or more layers of material. Thecapture needle is advanced through the delivery tube and through theloop in the proximal end of the elongated fastener. The capture needleis engaged with the distal end of the elongated fastener. The captureneedle is retracted to pull the distal end of the elongated fastenerthrough the loop to cinch the elongated fastener. The delivery tube andthe needle are separated from the elongated fastener.

In another embodiment, the delivery device is a multi-fire instrumentthat retains and delivers a plurality of fasteners. The fasteners can bedelivered sequentially or in parallel. The present delivered device canbe mounted to a variety of other instruments, such as for example, anendoscope.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various embodiments of thepresent disclosure, and, together with the description, serve to explainthe principles of the disclosure. In the drawings:

FIG. 1 illustrates a side view of a fastener in accordance with anembodiment of the present disclosure.

FIGS. 2a and 2b illustrate front and side views of a fixation system inaccordance with an embodiment of the present disclosure.

FIGS. 3a through 3h illustrate a method of tissue fixation utilizing thesystem of FIGS. 2a and 2b in accordance with an embodiment of thepresent disclosure.

FIG. 4a illustrates a side view of a fixation system deployed in anelongated, rigid state in accordance with an embodiment of the presentdisclosure.

FIG. 4b illustrates a side view of the fixation system of FIG. 4adeployed in a contracted, flexible state.

FIG. 5 illustrates a side view of a fastener with an inner member inaccordance with an embodiment of the present disclosure.

FIG. 6a illustrates a side sectional view of a fixation system shown inthe retracted state in accordance with an embodiment of the presentdisclosure.

FIG. 6b illustrates a side sectional view of the fixation system of FIG.6a shown in a deployed configuration.

FIGS. 7a through 7h illustrate a method of tissue fixation utilizing thesystem of FIGS. 6a and 6b in accordance with an embodiment of thepresent disclosure.

FIG. 8 illustrates a side view of a fastener including multipledetachment points in accordance with an embodiment of the presentdisclosure.

FIG. 9 illustrates a fastener including a loop on each end in accordancewith an embodiment of the present disclosure.

FIG. 10 is a perspective view of a self-locking fastener in accordancewith an embodiment of the present disclosure.

FIG. 11 is a perspective view of an alternate self-locking fastener inaccordance with an embodiment of the present disclosure.

FIGS. 12a-12c illustrates a delivery assembly for a self-lockingfastener in accordance with an embodiment of the present disclosure.

FIG. 12d illustrates the self-locking fastener of FIG. 11 secured to twoadjacent layer of material in accordance with an embodiment of thepresent invention.

FIG. 13a is a cross-sectional view of a self-locking fastener in alocked configuration in accordance with an embodiment of the presentdisclosure.

FIG. 13b is a cross-sectional view of an alternate self-locking fastenerin accordance with an embodiment of the present invention.

FIG. 14 is a cross-sectional view of an alternate self-locking fastenerin a locked configuration in accordance with an embodiment of thepresent disclosure.

FIG. 15 is a schematic illustration of interlock structures for aself-locking fastener in accordance with an embodiment of the presentdisclosure.

FIG. 16 is a schematic illustration of alternate interlock structuresfor a self-locking fastener in accordance with an embodiment of thepresent disclosure.

FIGS. 17a and 17b illustrate an alternate self-locking fastener inaccordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Reference will now be made in detail to the present embodiments of thedisclosure, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

The present disclosure provides devices, systems and method for coaptingor otherwise attaching tissue of a patient to a structure. Tissuefixation is used in many medical procedures, such as tissue repairprocedures, or procedures which cause the need for tissue repair.Numerous types of tissue may require fixation, such as ligaments andskin.

To facilitate an understanding of the disclosure, a number of terms aredefined below.

As used herein, the terms “subject” and “patient” refer to any animal,such as a mammal like livestock, pets, and preferably a human. Specificexamples of “subjects” and “patients” include, but are not limited, toindividuals requiring medical assistance, and in particular, requiringtissue fixation.

The present disclosure provides structures that embody aspects of thetissue fixation system. The present disclosure also provides fastenersimplanting in a patient for coapting tissue to a separate structure,such as an implantable mesh or other patient tissue. The illustrated andpreferred embodiments discuss these structures and techniques in thecontext of tissue fixation. These structures, systems, and techniquesare well suited for use in the field of surgery and other medicalprocedures. However, it should be appreciated that the disclosure isapplicable for use in other applications that affix a first structure toa second structure. The fixation devices, systems and method of thepresent disclosure have advantages over previous prior art devices.FIGS. 1-9 show various preferred embodiments of the fixation devices andsystems of the present disclosure. The present disclosure is not limitedto these particular configurations.

Referring now to FIG. 1, a preferred embodiment of a tissue fastener ofthe present disclosure is illustrated. Fastener 100 includes a first end101, and a second end, loop 102. Fastener 100 is configured to be usedwith one or more delivery assemblies used by a clinician such as asurgeon, to implant or otherwise deploy fastener 100 between tissue of apatient, and a second structure. Fastener 100 is a filamentous structureconstructed of one or more polymeric materials such as for example, afilament material. Fastener 100 may be made of materials which willremain intact, permanently implanted over long periods of time, such astimes greater than about 6 months, or more than about 24 months.

Alternatively, fastener 100 may be made of materials which bioabsorb,such as at a bioabsorption rate of more than about two years to lessthan about one month, or less than seven days. Numerous materials havebeen developed to be absorbed by the body, such as a magnesiumreinforced polymer. Numerous polymers can be used such as polymersselected from the group consisting of: polylactide, poylglycolide,polysaccharides, proteins, polyesters, polyhydroxyal kanoates,polyalkelene esters, polyamides, polycaprolactone, polyvinyl esters,polyamide esters, polyvinyl alcohols, polyanhydrides, polyolefins, PEEK,PTFE, and their copolymers, modified derivatives of caprolactonepolymers, polytrimethylene carbonate, polyacrylates, polyethyleneglycol, hydrogels, photo-curable hydrogels, terminal diols, andcombinations of these. Bioabsorbable fibers that reinforce abioabsorbable polymer matrix can be used. Filament materials can be madein permanent or absorbable matrices.

In an alternative embodiment, fastener 100 has a permanent portion, suchas a portion including loop 102 and neighboring material, and anabsorbable portion such as a portion including end 101. In thisconfiguration, end 101 and neighboring portions are used to assist indeployment and cinching of fastener 100. However once deployed, end 101and neighboring portions are unnecessary for fixation and arebioabsorbed.

Referring now to FIGS. 2a and 2b , side and top views of a preferredembodiment of a fixation system in accordance with an embodiment of thepresent disclosure are illustrated. A system includes fastener 100,preferably similar in construction to fastener 100 of FIG. 1, which isconfigured to be deployed using delivery assembly 200. A clinician, suchas a surgeon, uses delivery tool 200 to coapt tissue of a patient, to astructure, such as a mesh or additional tissue of the patient. The meshcan be used to create a support structure such as in a hernia repairprocedure or other procedure in which an additional support isbeneficial. Numerous biocompatible mesh materials can be used such asDacron mesh. The mesh can be placed within the body or on the surface ofthe skin such as in a procedure treating one or more patient burns.

Delivery tool 200 includes an elongate tube, housing 202 with internallumen 201. Housing 202 is preferably rigid, but may be flexible orinclude flexible portions such as hinged portions. Housing 202 may beconfigured to transition from rigid to flexible or vice versa, such asvia a mechanism, not shown but preferably selected from the groupconsisting of: hydraulic or pneumatic chambers, embedded shaped memorymaterial, insertable pre-shaped mandrels and combinations of these.

Housing 202 may include one or more markers, not shown but preferablymarkers selected form the group consisting of visible markers,ultrasonically reflective markers, radiopaque markers, electromagneticmarkers, and combinations of these. These markers may be used todetermine an insertion depth (e.g. into tissue) and/or otherwise orientdelivery tool 200 for tissue fixation or tool removal.

Housing 202 may have a circular cross-section, or alternative geometriesmay be employed. In alternative embodiments, cross-sectional geometrymay be oval, square, rectangular or trapezoidal, such as to create apreferred bending moment or for preferred insertion of one or moredevices into housing 202. Housing 202 may include one or more hingedportions, such as to allow controlled bending of housing 202 prior to,during or after tissue fixation.

Housing 202 is fixedly attached to penetrating portion 210, configuredto penetrate through the patient's tissue and any other material to becoapted to the patient's tissue. Penetrating portion 210 is shown as acurved needle construction, preferably rigid but alternativelyconstructed to controllably transition from flexible to rigid or viceversa as has been described above and is described below in reference toFIGS. 4a and 4b . Penetrating portion 210 includes a channel 211 whichis configured to receive fastener 100, with loop 102 at the proximal endof penetrating portion 210 (proximal to housing 202) and end 101 at thedistal end of penetration portion 210. The distal end of penetratingportion 210 includes sharpened tip 215, such as a pointed or beveledneedle tip, configured to penetrated tissue and the structure that thetissue is to be fixated to. In a preferred embodiment, tip 215 has asharp leading edge with a blunted trailing edge to avoid coring oftissue during insertion.

Penetrating portion 210 includes an opening, channel 211 which is sizedto allow fastener 100 to pass out of penetrating portion 210 during thefixation procedure. Channel 211 is preferably sized to approximate therelative diameter of fastener 100. In an alternative embodiment,penetration portion 210 comprises a rolled sheet of material, such asrolled Nitinol or stainless steel sheet, and an opening is formed byunfurling (unrolling) the sheet.

Delivery tool 200 further includes a grasping assembly, grasper 250which is slidingly received by housing 202 in lumen 201. Grasper 250includes deployable jaws 251 at its distal end. Grasper 250 is advancedthrough loop 102 of fastener 100 to a location proximate end 101 offastener 100. Jaws 251 are operated to grasp end 101 and retract end 101in order to cinch fastener 100 to tissue, as is described in detail inreference to FIGS. 3a through 3h . Grasper 250 is preferably connectedto a control such as a slide on a handle, control and handle not shownbut of similar construction to medical device handles and linkagecontrols, well known to those of skill in the art.

In an alternative embodiment, delivery tool 200 and the various fastenerdelivery tools of the present disclosure, include a power supply such asa battery and electronics used to operably control one or moremechanisms of delivery tool 200, and/or to deliver energy such asheating or welding energy used to cinch fastener 100. Activation ofdelivery tool 200 may be manual, such as via linkages and other controlsintegral to tool 200, or automatic or semi-automatic, such as via acontrol that activates a circuit controlling an electromechanicalassembly such as an assembly including a motor, solenoid, or a piezocrystal.

In another alternative embodiment, delivery tool 200 includes attachmentmeans configured to controllably maintain position of fastener 100 inpenetrating portion 200, and actively release fastener 100 during orafter fixation, attachment means not shown but preferably activated by acontrol on a handle of delivery tool 200.

In yet another alternative embodiment, the tissue fixation system isprovided in a kit form, including two or more fasteners. The two or morefasteners may be identical, or may have different features such asfeatures selected from the group consisting of: geometry such aspre-deployed geometry and deployed (cinch) geometry, length, width,stiffness, implantation life, melt temperature, and combinations ofthese.

Referring now to FIGS. 3a through 3h , paired side and top views of apreferred method of tissue fixation using the system of FIGS. 2a and 2bis illustrated. FIGS. 3a and 3b illustrate side and top views,respectively, of a first step in which delivery tool 200 and fastener100 are in a state ready for penetration into tissue (tissue andstructure to be fixated not shown). FIGS. 3c and 3d illustrate side andtop views, respectively, of a subsequent step in which delivery tool 200and fastener 100 have been inserted into tissue and a structure, grasper250 has been advanced through loop 102 of fastener 100, and jaws 251have grasped end 101 of fastener 100 (tissue and structure not shown).FIGS. 3e and 3f illustrate side and top views, respectively, of asubsequent step in which grasper 250 has been retracted such that end101 is pulled through loop 102 (tissue and structure to be fixated notshown). FIGS. 3g and 3h illustrate top and side views, respectively, ofthe step of FIGS. 3e and 3f , with tissue shown (fixated structure notshown). In a subsequent step, not shown, jaws 251 of grasper 250 wouldopen to release end 101 of fastener 100, and penetrating portion 210 ofdelivery tool 200 would be retracted form the tissue, leaving fastener100 in place in the tissue (fixated structure not shown).

Fastener 100 can be left as described immediately above, with africtional engagement. Alternatively or additionally, fastener 100 canbe further secured, such as via adhesive (not shown but preferably anadhesive delivery mechanism integral to delivery tool 200).Alternatively or additionally, fastener 100 can be further secured, suchas via heating or welding by delivery tool 200 (not shown but preferablyan energy delivery mechanism integral to delivery tool 200), or anyother physical or chemical method of bonding. As used herein, “bond” or“bonding” refers to, for example, physical, mechanical, and/or chemicaltechniques, such as for example, adhesive bonding, solvent bonding,ultrasonic welding, thermal bonding, suitable for securing ends of afastener.

Referring now to FIGS. 4a and 4b , a preferred embodiment of a fixationsystem of the present disclosure is illustrated. Delivery tool 200′ issimilar in construction and function to delivery tool 200 of FIGS. 2aand 2b , but is additionally configured to have penetrating portion 210′transition from a rigid state to a flexible or semi-rigid state, and/orvice versa. Alternatively or additionally, delivery tool 200′ isconfigured to change geometry, such as to transition from an expandedstate to a contracted state, and/or vice versa. Referring specificallyto FIG. 4a , penetrating portion 210′ is shown in an expanded, rigidstate.

Referring specifically to FIG. 5b , penetrating portion 210′ is shown ina contracted, semi-rigid state. Rigidity may be manipulated to encircletissue and establish tissue penetrating pathways. Rigidity may bemanipulated prior to or during insertion, or prior to or duringretraction. In a preferred embodiment, the rigidity and/or shaping isachieved by changing states of a shaped memory material, such as via atemperature change. Alternatively or additionally, the rigidity and/orshaping are achieved through the use of one or more of: hydraulics,pneumatics, or insertion of a pre-shaped or shapeable mandrel. Tip 251′can selectively be made rigid, semi-rigid or flexible to allow foraccess to restricted spaces. State change can be performed prior tomovement, or to be formed into a preferred position. Rigidity and/orshape change is preferably activated by a control on a handle todelivery tool 200′ (handle and control not shown). Activation can beaccomplished with an electromechanical assembly, such as abattery-controlled module configured to heat a Nitinol wire, causingcontraction. Alternatively or additionally, other mechanical componentscan be employed such as springs, cams and/or levers.

Referring now to FIG. 5, another preferred embodiment of a tissuefastener of the present disclosure is illustrated. Fastener 300 includesa first end 301, and a second end, loop 302. Fastener 300 is configuredto be used with one or more delivery assemblies used by a clinician suchas a surgeon, to implant or otherwise deploy fastener 100 between tissueof a patient, and a second structure. Fastener 300 is a filamentousstructure constructed of one or more polymeric materials, such as forexample, a filament material. Fastener 300 may be made of materialswhich will remain intact, permanently implanted over long periods oftime, such as times greater than about 6 months, or more than about 24months. Alternatively, fastener 100 may be made of materials whichbioabsorb, such as has been described above in reference to FIG. 1.

Fastener 300 further includes insert 303, an elongate structure withinthe outer surface of fastener 300. In one embodiment, insert 303 is amalleable filament configured to allow fastener 300 to plasticallydeform and maintain the deformed shape, such as prior to, during, orafter fixation of tissue to a structure. In an alternative embodiment,insert 303 is a resiliently biased material, such as a materialconfigured to maintain the relatively linear geometry shown in FIG. 5,or to bias fastener 300 in the cinched state (cinched bias not shown).

Referring now to FIGS. 6a and 6b , a preferred embodiment of a tissuedelivery tool of the present disclosure is illustrated. Delivery tool400 includes housing 420 which slidingly receives shaft 403. Housing 420may be made of rigid, semi rigid or flexible materials. Alternatively,housing 420 may be configured to transition from rigid to flexible,and/or vice versa, as has been described in detail above. Shaft 403 hasa proximal end and a distal end. On the proximal end of shaft 503 isknob 401. Shaft 403 further includes step 402 which is configured tolimit advancement of shaft 403 into housing 420. In a preferredembodiment, stop 402 is adjustable such as via sliding or rotating stop402 along shaft 420. Shaft 520 includes insertion line 421, which isused by an operator such as a clinician to properly advance or positiondelivery tool 400 into tissue or otherwise. Line 421 may be a visiblemarker, a radiopaque marker, an ultrasonically reflective surface, anelectromagnetic marker, or combinations of these.

At the distal end of shaft 420 is expandable needle assembly 410. Needleassembly 410 includes stationary needle 411 and pivoting needle 412.Stationary needle 411 is rotatably attached to pivoting needle 412 attip 415, pivot not shown but preferably a miniature hinge configured tobe closed by rotation of knob 401. Alternatively or additionally, needleassembly 410 may be expanded or contracted through activation of a shapememory alloy such as Nitinol. Tip 415 is a sharpened tip configured topenetrate tissue and the structure to be fixated to the tissue. Tip 415is preferably configured to avoid coring of tissue.

Referring specifically to FIG. 6a , delivery tool 400 is shown withshaft 403 retracted and needle assembly 410 in a compacted statemaintained within housing 420. In FIG. 6b , needle assembly 410 isexpanded, either by resilient bias or a controllable hinge, such as ahinge opened by rotation of knob 401. In operation, and as described inreference to FIGS. 7a through 7h , needle assembly 410 of delivery tool400 surrounds a fastener, such as a fastener described in reference toFIG. 1 or FIG. 5. When needle assembly 410 is in the expanded state ofFIG. 6b , the fastener is able to exit both stationary needle 411 andpivoting needle 412, via a slot or other opening in each, slots notshown but described in detail in reference to FIGS. 7a through 7 h.

Referring now to FIGS. 7a through 7h , side sectional views of apreferred method of tissue fixation using the system of FIGS. 6a and 6bis illustrated. In FIG. 7a , delivery tool 400 is positioned with tip415 above a mesh which is above tissue to which the mesh is to becoapted. The mesh may be a Dacron or other biocompatible mesh that isoften affixed to tissue. Alternatively, the tissue may be affixed toother tissue, such as when two pieces of tissue are closed together in asurgical procedure. Shaft 403 is positioned such that needle assembly410 is in its compacted state within housing 420. A fastener 300, suchas fastener 300 of FIG. 5, has been previously loaded into needleassembly 410.

FIG. 7b illustrates a subsequent step in which tip 415 has been advancedthrough the mesh and tissue, but shaft 403 has not moved relative tohousing 420. In a preferred embodiment, shaft 403 may be maintained inrelative position to 420 during insertion, such as via a set screw,compressible collar, movable mechanical stop, or other frictional ormechanical engagement means, engagement means not shown.

FIG. 7c illustrates a subsequent step in which shaft 403 has beenadvanced such that needle assembly 410 exits housing 420 and expandsinto a “V” configuration. Pivoting needle 412 rotates away fromstationary needle 411 at tip 415. Fastener 300 remains within needleassembly 410, however fastener 300 expands in the same geometry asneedle assembly 410. Fastener 300 may be held in place by holding means,not shown, or may be shaped such as to maintain in place.

FIG. 7d illustrates a subsequent step in which the distal end ofpivoting needle 412, tip 413, has advanced through the tissue and thenthe mesh, in the “V” configuration, as shaft 403 is retracted (housing420 is kept in place).

FIG. 7e illustrates a subsequent step in which fastener 300 has passedthrough an opening in pivoting needle 412 (opening not shown butpreferably oriented toward stationary needle 411. Fastener 300 may havebeen mechanically released such as via a pull wire or other techniques.Needle assembly 410 is advanced such that tip 413 moves distally and outof the tissue-mesh interface, leaving fastener 300 in place which loop302 positioned above the mesh.

FIG. 7f illustrates a subsequent step in which pivoting needle 412 hasrotated such that needle assembly 410 is in its compact, linear state.Rotation of pivoting needle 412 is accomplished by a controllable bias,a controllable hinge, or other manual or automatic pivoting means. Inone embodiment, a collar is attached to a pull wire, the collarsurrounding and compacting needle assembly 410, collar not shown.Advancement of the collar allows needle assembly 410 to expand withpivoting needle 412 pivoting away from stationary needle 411. Retractionof the collar capture pivoting needle 412, pivoting it toward stationaryneedle 411 until the collar surrounds pivoting needle 412 and stationaryneedle, maintaining needle assembly 410 in its compact, linear state.

FIG. 7g illustrates a subsequent step in which delivery tool 400 hasbeen retracted and removed from the tissue and mesh, leaving fastener300 in place with loop 302 above the mesh, the middle portion offastener 300 extending from the top of the mesh to the bottom of thetissue, then from the bottom of the tissue to the top of the mesh, withend 101 above the mesh.

FIG. 7h illustrates a subsequent step in which end 301 has been passedthrough loop 302 and fastener 300 is ready to be cinched tight, fixatingthe mesh to the tissue. Alternatively or additionally, loop 302 and end301 can be fixedly attached with glue, heat and/or welding, as has beendescribed above.

Referring now to FIG. 8, a side view of a preferred embodiment of afastener of the present disclosure is illustrated. Fastener 100′includes end 101 and opposite end, loop 102. Along the mid-portion offastener 100′ are notches 103, configured to allow an operator to detacha selectable portion of fastener 100′ after end 101 has passes throughloop 102 and fastener 100′ has been cinched around tissue and/or astructure. Fastener 100′ further includes marker 104, such as a visible,radiopaque, ultrasonic, or electromagnetic marker configured to assistin placement of fastener 100′ and/or confirm subsequent fixation offastener 100′.

Referring now to FIG. 9, a side view of another preferred embodiment ofa fastener of the present disclosure is illustrated. Fastener 100″includes loop 102 a on one end and loop 102 b on the other end. Fastener100″ can be used in the various devices of the present disclosure,avoiding the need for orientation of fastener 100″. Loop 102 a can beconfigured to pass through loop 102 b, as the non-looped ends describedabove. In another embodiment, multiple loops can be used to perform afunction, such as in attachment to other fasteners to provide a loopstructure for cinching. Loop 102 a and loop 102 b may be of similargeometry or construction or different.

FIG. 10 illustrates self-locking fastener 500 in accordance with anembodiment of the present invention. The self-locking fastener 500includes proximate portion 502 connected to filament portion 504. Distalend 506 of the filament portion 504 is configured to form a self-lockingmechanically interlock with the proximate portion 502. As used herein,“self-locking” refers to a mechanical interlock between differentportions of a fastener in at least one direction of travel. Theself-locking feature is preferably only in one direction so the surgeoncan incrementally tighten or cinch as needed.

A variety of self-locking structures can be used. In one embodiment, theself-locking structures include a multi-filament first portion and asecond portion having interlock structures that mechanically engagedwith the first portion. As used herein, “multi-filament” refers to avariety of structures, such as for example, woven, non-woven,interlaced, perforated, penetrable, braided, and a variety of otherstructures. The multi-filament portion of the fastener can be a naturalmaterial, such as for example, cotton or silk, or a polymeric material,such as polylactide, poylglycolide, polysaccharides, proteins,polyesters, polyhydroxyal kanoates, polyalkelene esters, polyamides,polycaprolactone, polyvinyl esters, polyamide esters, polyvinylalcohols, polyanhydrides, polyolefins, PEEK, PTFE, Dacron and theircopolymers, modified derivatives of caprolactone polymers,polytrimethylene carbonate, polyacrylates, polyethylene glycol,hydrogels, photo-curable hydrogels, terminal diols, and combinationsthereof. In some cases filament materials are coated, encapsulated, orblended with antimicrobial substances to reduce chances of woundinfections and/or antibiotics and growth proteins for enhance healing ofruptured tissues.

In another embodiment, the self-locking structures include molded,rolled sheets or extruded first and/or second portions that mechanicallyinterlock, with or without the use of a multi-filament portion. A widevariety of interlocking structures are possible, including but notlimited to molded structures and structures that are manufactured inmultiple steps.

“Interlock structure” refers to prongs, barbs, protrusions, hooks,extensions, teeth, textured surfaces, and the like. The interlockstructures can be discrete features added to the self-locking fastener;molded or extruded as part of the self-locking fastener; formed bypost-processing the self-locking fastener; and/or a variety of otherapproaches. In one embodiment, the first portion of the fastener is aloop structure and the second portion is a hook structure, such as in ahook-and-loop fastener.

In the illustrated embodiment, sleeve portion 502 is a hollow,multi-filament material 514 and the filament portion 504 is amonofilament configured to be inserted into opening 508. In an alternateembodiment, the sleeve portion 502 may be a textile structure, extrudedtubing, or a molded or roll-formed part.

At least a portion of the filament portion 504 includes a plurality ofinterlock structures 510 configured to interlock through internalsurface 512 of sleeve portion 502. The interlock structures 510preferably penetrate the multi-filament sleeve portion 502 to form asecure self-locking mechanical interlock. See e.g., FIG. 13. The angleof the interlock structures 510 permit the distal end 506 to advance asfar into the opening 508 as needed to tighten the filament portion 504.

The interlock structures 510 are preferably made during a postprocessing step, such as for example, by creating small cuts in thefilament portion 504, as will be discussed in more detail below.Alternatively, the interlock structures 510 can be molded as part of thefilament portion 504, overmolded onto the filament portion 501, discretestructures attached or bonded to the filament portion 504, or a varietyof other techniques.

In the illustrated embodiment, portion 516 of the multi-filamentmaterial 514 extends along a portion of the length of the filamentportion 504 to form a permanent connection with the sleeve portion 502.In one embodiment, the portion 516 of the multi-filament material 514 isbonded to the monofilament 504. In another embodiment, portion 516mechanically engages with interlock structures on the filament portion504. In yet another embodiment, separate mechanical interlocks, such asfor example, pins, staples, bands, can be used to form a permanentconnection between the sleeve portion 502 and the filament portion 504.

FIG. 11 illustrates an alternate self-locking fastener 530 in accordancewith an embodiment of the present disclosure. The penetrating portion532 illustrated in FIGS. 12a-12c is removed for the sake of clarity.Hollow sleeve portion 534 is fitted on distal end 536 of delivery tube538. Capture needle 540 extends through delivery tube 538 with hook 542positioned to engage with loop 544 at distal end 546 of filament portion548. Interlock structures 550 located on filament portion 548 areconfigured to self-lock with internal surface 552 of the hollow sleeveportion 534. Once the filament portion 548 is engaged with the hollowsleeve portion 534, the interlock structures 550 resist disengagement indirection 554. The filament portion 548, however, can be advancedfurther into the hollow sleeve portion 534 in direction 556 to tightenor cinch the self-locking fastener 530.

The loop 544 can be formed using a variety of techniques, such as forexample, bending a single strand of filament material 548 back onitself, molding the loop 544 in the distal end 546, attaching a separateloop structure to the distal end 546, and the like. In one embodiment,distal end 546 is a discrete molded component designed to be secured inthe penetrating portion 532 and to couple with the capture needle 540.In another embodiment, the distal end 546 is a multi-filament structurethat the capture needle 540 can penetrate and capture.

FIG. 12a-12c illustrate operation of the self-locking fastener 530 ofFIG. 11 located in delivery assembly 570. The delivery assembly 570includes penetrating portion 532 with sharp tip 572 to penetrate tissue,bone, reinforcing fabrics, and the like. Filament portion 548 is locatedin an open channel formed in the penetrating portion 532. Sleeve portion534 is located within housing 574.

As best illustrated in FIG. 12b , the capture needle 540 extends out ofthe housing 574 until hook 542 passes through loop 544 and captures thefilament portion 548. The capture needle 540 is then retracted into thehousing 574 so that interlock structures 550 self-locks with interiorsurface 552 of the sleeve portion 534. The entire self-locking fastener530 is then released from the delivery assembly 570. Even with thedelivery assembly 570 removed, the surgeon has the option to furthertension the distal end 546 of the filament portion 548 further into thesleeve portion 534 to tighten or cinch the fastener 530.

FIG. 12d illustrates self-locking fastener 530 securing layer 558 a tolayer 558 b (collectively “558”). The layers 558 can be tissue, bone, aprosthetic device, such as for example, a reinforcing mesh, and thelike. The surgeon can advance distal end 546 in direction 556 to tightenor cinch loop 562 formed by the filament portion 548.

FIG. 13a is a side sectional view of a self-locking fastener 600 engagedwith a sleeve portion 602 in accordance with an embodiment of thepresent invention. In the illustrated embodiment, sleeve portion 602 isa multi-filament structure in the illustrated embodiment. As the surgeonadvances filament portion 604 through opening 606 in the sleeve portion602 in direction 608, the interlock structures 610 deflect inward towardthe core 612. Once the surgeon achieves the desired tension on thefilament portion 604, the filament portion 604 is displaced slightly indirection 614 until the interlock structures 610 advances into themulti-filament sleeve portion 602. The surgeon can re-tension thefilament portion 604 by applying a force in the direction 608. Theinterlock structures 610 then reset into the multi-filament sleeveportion 602 to form a self-locking mechanical interlock.

In order for the interlock structures 610 to open a sufficient amount tosecurely engage with the multi-filament sleeve portion 602, clearance620 is preferably maintained between outer surface 622 of the core 612and inner surface 624 of the sleeve portion 602. The distance betweeneach interlock structure 610 is a reflection of number of interlockstructures per unit length represented as interlock structure density.The interlock structure density may be interdependent on the number ofinterlocks and filament strength for the application. Increasing thenumber of interlock structures may produce higher load bearingcapacities of the assembly.

The distance of the interlock structure tips 626 to the outer surface622 can be characterized as interlock structure height 628. Interlockstructure height 628 is preferably sufficient so the interlockstructures 610 can penetration or otherwise advance into themulti-filament sleeve 602. Adequate clearance 620 between the filamentsurface 622 and multi-filament sleeve 602 is required for the interlockstructures 610 to consistently engage with inner surface 624 of themulti-filament sleeve 602. Consequently, there is an optimumrelationship between interlock structure height 628 and clearance 620.In one embodiment, the clearance 620 is between about one-third to aboutone-half of interlock structure height 628. Thus, the remaining height628 of the interlock structure 610 is available for penetration andinterlocking with the multi-filament sleeve 602. In another embodiment,the clearance 620 is between about 5% to about 95% of the interlockstructure height 628, and typically about 30%.

The depth of cut 630 reduces the pull strength of the filament portion604. To optimize the performance of a self-locking filament 600, it isadvantageous to consider varying the interlock structure geometry (cutangle, cut depth, cut length, cut distance, etc.) and/or the spatialarrangement of the interlock structures. Varying these features shouldnot only enhance the tensile strength of a filament, but also shouldenhance the ability of the interlock structures to form a secureself-locking configuration to hold and maintain wound edges together.

Unlike conventional filaments, which place tensions directly at theknots, the fasteners 600 spread out the tension along length 636 of thesleeve portion 602. Optimizing the disposition and/or the configurationof the interlock structures 610 should therefore further increase theeffectiveness of the self-locking function to maximize holding strengthand minimize the gap formation along the wound edges. The latter isparticularly beneficial for promoting wound healing.

FIG. 13b illustrates an alternate embodiment of the self-lockingfastener 600 in which sleeve portion 602 is a textile structure thatassumes a necked-down configuration 632 when tension force 634 isapplied in accordance with an embodiment of the present invention.Tension force 634 causes sleeve portion 602 to constrict or cinch aroundfilament portion 604. The interlock structures 610 are driven furtherinto the sleeve portion 602, enhancing the mechanical interlock. Thetension force 634 is preferably applied by the delivered assembly 570before releasing the self-locking fastener 600. In one embodiment, thesleeve portion 602 is bonded to the filament portion 604 in thenecked-down configuration 632.

FIG. 14 illustrates an alternate self-locking fastener 650 withinterlock structures 652 located on interior surface 654 of sleeve 656.The sleeve 656 can be a molded structure rather than the multi-filamentstructure discussed above. As the filament portion 658 is advancedthrough opening 660 in direction 662, the interlock structures 652deflect. Tension on the filament portion 658 in direction 664, however,is resisted by the interlock structures 652 engaging with the filamentportion 658 to form the self-locking configuration. The filament portion658 is preferably a multi-filament material that permits the interlockstructures 652 to penetrate, as illustrated in FIG. 14.

FIG. 15 is a schematic illustration of the relation between variousself-locking parameters, as represented by the following equation.

L _(c) =D _(c)/sin(180−θ)

Where:

L_(c)=Length of the cut

D_(c)=Depth of the cut

P=Distance between the cuts

θ=Cut angle in degrees

P=Interlock structure pitch

For example, when the cut angle θ is about 152° and keeping the lengthof cut L_(c) to a maximum of about 0.59 millimeters (hereinafter “mm”),the depth of cut D_(c) is about 0.25 mm. With a cut angle θ of about172° and the length of cut L_(c) about 0.34 mm, the depth of cut D_(c)is about 0.043 mm.

FIG. 16 illustrates an alternate self-locking fastener 700 in which thecutting blade moves along longitudinal axis 702 of the fiber 704 indirection 706 after reaching the maximum depth of cut D_(c). The amountof longitudinal motion 706 of the blade is identified as X. A portion ofthe polymeric material displaced by the longitudinal motion X is addedto the interlock structure 700 and increases the overall interlockstructure height H_(p) and the length of the cut L_(c). In anotherembodiment, the motion of the cutting blade can be adjusted to vary thelength of the cut L_(c), thus changing the interlock structure heightH_(p), without changing the depth of cut D_(c).

FIGS. 17a and 17b illustrate an alternate self-locking fastener 720 inaccordance with an embodiment of the present invention. Sleeve portion722 is an extruded or molded polymeric structure with a plurality ofholes 724. The holes 724 can be made during the extrusion or moldingprocess, or added during a post processing step. Filament portion 726includes a plurality of interlock structures 728 configured to self-lockwith the holes 724.

As best illustrated in FIG. 17b , as the filament portion 726 is advanceinto opening of the sleeve portion 722 in direction 730, the interlockstructures 728 deflect toward the core 732. Once the surgeon achievesthe desired tension on the filament portion 726, the filament portion726 is displaced slightly in direction 734 until some or all of theinterlock structures 728 penetrate a hole 724. The surgeon canre-tension the filament portion 726 by applying a force in the direction730. The interlock structures 728 then reset into a different hole 724to form a self-locking mechanical interlock.

The filamentous tissue implants of the present disclosure can be used tosecure tissue of patient to another structure, such as an artificialimplant, a mesh material, or other patient tissue. In preferredembodiments, the filamentous tissue implant has a loop on one end, usedto tie a knot, or otherwise cinch, by passing the non-looped end throughtissue and other structures, and then through the loop. Cinching can becaused by frictional engagement and/or it may include other fixationmeans such as a weld (the filamentous implant to itself or anotherimplant), adhesive, interlock structure configuration, webbing, pre-tiedknots, connection to a second component; etc.

Systems of the present disclosure may include one or more energy sourcessuch as to cinch a fastener. Heating and welding can be used to providetemporary or permanent fixation of one part of the fastener to theother. Energy sources may also be used to activate grasping mechanisms,position one or more components or assemblies of the delivery tool,activate a tensioning mechanism such as a mechanism used to cinch afastener, or for other purposes requiring energy.

Numerous kit configurations are also to be considered within the scopeof this application. A fixation system is provided with one or morefasteners, and one or more delivery assemblies.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range is encompassed within the embodiments of the invention. Theupper and lower limits of these smaller ranges which may independentlybe included in the smaller ranges is also encompassed within theembodiments of the invention, subject to any specifically excluded limitin the stated range. Where the stated range includes one or both of thelimits, ranges excluding either both of those included limits are alsoincluded in the embodiments of the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the embodiments of the present disclosure belong.Although any methods and materials similar or equivalent to thosedescribed herein can also be used in the practice or testing of theembodiments of the present disclosure, the preferred methods andmaterials are now described. All patents and publications mentionedherein, including those cited in the Background of the application, arehereby incorporated by reference to disclose and described the methodsand/or materials in connection with which the publications are cited.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the embodiments of thepresent invention are not entitled to antedate such publication byvirtue of prior invention. Further, the dates of publication providedmay be different from the actual publication dates which may need to beindependently confirmed.

Other embodiments of the invention are possible. Although thedescription above contains much specificity, these should not beconstrued as limiting the scope of the invention, but as merelyproviding illustrations of some of the presently preferred embodimentsof this invention. It is also contemplated that various combinations orsub-combinations of the specific features and aspects of the embodimentsmay be made and still fall within the scope of the present disclosure.It should be understood that various features and aspects of thedisclosed embodiments can be combined with or substituted for oneanother in order to form varying modes of the disclosed embodiments ofthe invention. Thus, it is intended that the scope of at least some ofthe present invention herein disclosed should not be limited by theparticular disclosed embodiments described above.

Thus the scope of this invention should be determined by the appendedclaims and their legal equivalents. Therefore, it will be appreciatedthat the scope of the present invention fully encompasses otherembodiments which may become obvious to those skilled in the art, andthat the scope of the present invention is accordingly to be limited bynothing other than the appended claims, in which reference to an elementin the singular is not intended to mean “one and only one” unlessexplicitly so stated, but rather “one or more.” All structural,chemical, and functional equivalents to the elements of theabove-described preferred embodiment(s) that are known to those ofordinary skill in the art are expressly incorporated herein by referenceand are intended to be encompassed by the present claims. Moreover, itis not necessary for a device or method to address each and everyproblem sought to be solved by the present invention, for it to beencompassed by the present claims. Furthermore, no element, component,or method step in the present disclosure is intended to be dedicated tothe public regardless of whether the element, component, or method stepis explicitly recited in the claims.

Other embodiments of the disclosure will be apparent to those skilled inthe art from consideration of the specification and practice of thedisclosure disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims. In addition,where this application has listed the steps of a method or procedure ina specific order, it may be possible, or even expedient in certaincircumstances, to change the order in which some steps are performed,and it is intended that the particular steps of the method or procedureclaim set forth below not be construed as being order-specific unlesssuch order specificity is expressly stated in the claim.

We claim:
 1. A method of engaging a tissue fixation system to two ormore layers of material, the method comprising the steps of: coupling anelongated fastener to an elongated curved needle, the elongated curvedneedle comprising a proximal end attached to a delivery tube and adistal end configured to penetrate the two or more layers of material;inserting the distal end of the elongated curved needled and a portionof the elongated fastener though the two or more layers of material;advancing a capture needle through the delivery tube and through atleast one loop in the elongated fastener; mechanically capturing theelongated fastener with the capture needle; retracting the captureneedle through the deliver tube; pulling the elongated fastener throughthe loop to cinch the elongated fastener to the two or more layers ofmaterial; and detaching the delivery tube and the elongated curvedneedle from the elongated fastener.